3 Oak Road 
Fairfield, NJ 07004

973-276-9600
844-740-7500

E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

05 / 16 / 2017

Regulatory Affairs Specialist

The RA Specialist is responsible for assisting in developing and maintaining all regulatory documentation. 

 In addition this role:

  • Collect and coordinate information and prepare regulatory documentation for submission such as ANDAs, Annual Reports, Supplements, labeling, registration etc.
  • Provide Pharmaco-vigilance assistance.
  • Maintain regulatory files/database and chronologies for completeness and easy retrieval.
  • Establish and maintain system for tracking regulatory documents, Quality Agreements, and Audit Checklists.

The Regulatory Affairs Specialist is a full-time position based in Fairfield, NJ.
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